IP Library › Granted Patent US 12,268,879
Granted Patent B2
US 12,268,879 · App. 17/472,139 · Granted Apr 8, 2025

Autotitration of therapy using detected electrical activity

Inventors: Xin Su (Plymouth, MN); Thaddeus S. Brink (St. Paul, MN); Dwight E. Nelson (Shoreview, MN)
Assignee: Medtronic, Inc.
A61N1/36139A61B5/388A61N1/36007A61N1/36146A61N1/37241A61N1/36107G16H20/30
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Quick Facts
Patent No.
US 12,268,879
App. No.
17/472,139
Granted
Apr 8, 2025
Kind
B2
Abstract

This disclosure relates to devices, systems, and methods for autotitrating stimulation parameters. In one example, a method includes controlling an implantable medical device to deliver electrical stimulation to a patient according to a plurality of electrical stimulation parameter sets, each electrical stimulation parameter set of the plurality of electrical stimulation parameter sets defining a respective electrical stimulation signal deliverable to the patient, obtaining, by one or more processors and for each electrical stimulation parameter set of the plurality of electrical stimulation parameter sets, a respective signal representative of an electrical response sensed from the patient in response to the electrical stimulation delivered to the patient according to the respective electrical stimulation parameter set, and determining, by the one or more processors and based on the obtained respective signals, a primary electrical stimulation parameter set that defines electrical stimulation therapy deliverable to the patient by the implantable medical device.

Claims (48)

1. A medical system comprising:

an implantable medical device (IMD); and

a lead coupled to the IMD, the lead comprising a plurality of electrodes, the plurality of electrodes comprising at least one stimulation electrode configured to deliver electrical stimulation to a target tissue site of a patient and at least one sensing electrode configured to sense one or more bioelectrical signals from the patient,

wherein the IMD comprises:

a stimulation generator programmed to deliver, via the at least one stimulation electrode, electrical stimulation to the patient according to a plurality of electrical stimulation parameter sets, each electrical stimulation parameter set of the plurality of electrical stimulation parameter sets defining a respective electrical stimulation signal deliverable to the patient; and

one or more processors configured to:

control the stimulation generator to deliver, via the at least one stimulation electrode, electrical stimulation to the target tissue site based on the plurality of electrical stimulation parameter sets;

obtain, via the at least one sensing electrode and for each electrical stimulation parameter set of the plurality of electrical stimulation parameter sets, a respective signal representative of a bioelectrical response corresponding to muscle fiber or nerve activity sensed by the at least one sensing electrode from the patient in response to the electrical stimulation delivered to the patient according to the respective electrical stimulation parameter set;

titrate electrical stimulation to determine, based on the obtained respective signals, a primary electrical stimulation parameter set that defines electrical stimulation therapy deliverable to the patient by the stimulation generator;

control delivery of the electrical stimulation therapy to the patient according to the primary electrical stimulation parameter set;

periodically titrate electrical stimulation to determine, based on the obtained respective signals, a new primary electrical stimulation parameter set that defines electrical stimulation therapy deliverable to the patient by the stimulation generator; and

control delivery of the electrical stimulation therapy to the patient according to the new primary electrical stimulation parameter set.

2. The system of claim 1 , wherein the lead is an implantable lead.

3. The system of claim 1 , wherein the one or more processors are configured to determine the primary electrical stimulation parameter set based on characteristics of the obtained respective signals.

4. The system of claim 3 , wherein the characteristics comprise at least one of voltage amplitude, current amplitude, frequency, timing, or duration.

5. The system of claim 1 , wherein the one or more processors are configured to determine the primary electrical stimulation parameter set based on characteristics of the obtained respective signals in a single anatomical region of the patient.

6. The system of claim 1 , wherein the one or more processors are configured to determine the primary electrical stimulation parameter set based on characteristics of the obtained respective signals in more than one anatomical region of the patient.

7. The system of claim 1 , wherein one or more processors are configured to determine the primary electrical stimulation parameter set based on interpolating a response curve based on the obtained respective signals.

8. The system of claim 1 , wherein the one or more processors are further configured to:

determine a response curve based on the obtained respective signals, wherein the one or more processors are configured to determine the primary electrical stimulation parameter set based on a projected value along the response curve.

9. The system of claim 1 , wherein the bioelectrical response comprises at least one of a direct response, an oligosynaptic reflex response, or a polysynaptic reflex response.

10. The system of claim 1 , wherein the target tissue site is proximate a sacral nerve or a pudendal nerve.

11. The system of claim 1 , wherein the system is configured to treat incontinence or overactive bladder in the patient.

12. The system of claim 1 , wherein the system is configured to deliver at least one of spinal cord stimulation, gastric stimulation, peripheral nerve stimulation, or occipital nerve stimulation.

13. The system of claim 1 , wherein the primary electrical stimulation parameter set is associated with a measured response having a greatest amplitude.

14. The system of claim 1 , wherein the primary electrical stimulation parameter set is associated with a measured response that is less than a predetermined threshold.

15. The system of claim 1 , wherein the plurality of electrical stimulation parameter sets are predetermined.

16. The system of claim 1 , wherein a first electrical stimulation parameter set of the plurality of electrical stimulation parameter sets is predetermined and a second electrical stimulation parameter set of the plurality of electrical stimulation parameter sets is based on the respective signal representative of the bioelectrical response to the electrical stimulation delivered to the patient according to the first electrical stimulation parameter set.

17. The system of claim 1 , wherein each of the plurality of electrical stimulation parameter sets comprises at least one parameter that is different from a parameter of each other of the plurality of electrical stimulation parameter sets.

18. The system of claim 1 , wherein the one or more processors are configured to titrate in response to determining a change in a posture of the patient.

19. The system of claim 1 , wherein the one or more processors are configured to titrate in response to receiving feedback from the patient.

20. The system of claim 1 , wherein the one or more processors are configured to titrate based on a determination that the at least one stimulation electrode has moved.

21. The system of claim 1 , wherein the one or more processors are configured to titrate based on receiving a request to titrate from an external device.

22. The system of claim 1 , wherein the stimulation generator is further configured to iteratively deliver electrical stimulation to the patient according to each electrical stimulation parameter set of the plurality of electrical stimulation parameter sets and obtain the respective signal representative of the electrical response sensed from the patient in response to the electrical stimulation delivered to the patient according to each electrical stimulation parameter set.

23. The system of claim 1 , wherein the signal representative of the electrical response sensed from the patient comprises an electromyographic (EMG) signal of the patient.

24. The system of claim 1 , wherein the signal representative of the electrical response sensed from the patient comprises a nerve recording of an active potential of one or more nerves of the patient.

25. The system of claim 1 , wherein the implantable medical device is configured to deliver electrical stimulation to a first tissue and sense the electrical response from a second tissue different than the first tissue.

26. The system of claim 1 , wherein each electrical stimulation parameter set comprises a signal amplitude, a pulse width, a pulse frequency, a frequency of bursts of pulses, a number of pulses within each burst of pulses, a duty cycle, and an electrode configuration.

27. A method comprising:

controlling, by one or more processors of an implantable medical device (IMD), a stimulation generator of the IMD to deliver, via at least one stimulation electrode of a plurality of electrodes of a lead, the lead coupled to the IMD, electrical stimulation to a target tissue site of a patient based on a plurality of electrical stimulation parameter sets, wherein the stimulation generator is programmed to deliver, via the at least one stimulation electrode, electrical stimulation to the patient according to the plurality of electrical stimulation parameter sets, each electrical stimulation parameter set of the plurality of electrical stimulation parameter sets defining a respective electrical stimulation signal deliverable to the patient;

obtaining, by the one or more processors via at least one sensing electrode of the plurality of electrodes configured to sense one or more bioelectrical signals from the patient, and for each electrical stimulation parameter set of the plurality of electrical stimulation parameter sets, a respective signal representative of a bioelectrical response corresponding to muscle fiber or nerve activity sensed by the at least one sensing electrode from a patient in response to the electrical stimulation delivered to the patient according to the respective electrical stimulation parameter set;

titrating, by the one or more processors, electrical stimulation to determine, based on the obtained respective signals, a primary electrical stimulation parameter set that defines electrical stimulation therapy deliverable to the patient by the stimulation generator controlling delivery, by the one or more processors, of the electrical stimulation therapy to the patient according to the primary electrical stimulation parameter set; and

periodically titrating, by the one or more processors, electrical stimulation to determine, based on the obtained respective signals, a new primary electrical stimulation parameter set that defines electrical stimulation therapy deliverable to the patient by the stimulation generator; and

controlling delivery of the electrical stimulation therapy to the patient according to the new primary electrical stimulation parameter set.

28. The method of claim 27 , wherein the determining the primary electrical stimulation parameter set is based on characteristics of the obtained respective signals.

29. The method of claim 28 , wherein the characteristics comprise at least one of voltage amplitude, current amplitude, frequency, timing, or duration.

30. The method of claim 27 , wherein the determining the primary electrical stimulation parameter set is based on characteristics of the obtained respective signals in a single anatomical region of the patient.

31. The method of claim 27 , wherein the determining the primary electrical stimulation parameter set is based on characteristics of the obtained respective signals in more than one anatomical region of the patient.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 10, 2021
From: SU, XIN; BRINK, THADDEUS S.; NELSON, DWIGHT E.
To: MEDTRONIC, INC.
Reel/Frame 057451/0289 →
Continuity (3)
Continuation 16344719
Provisional Application 62414396 · Oct 28, 2016
Related Publication 20220080206A1 · Mar 17, 2022
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